Compliance with confidence

Welcome to Brandwood CKC, a trusted regulatory partner to the biomedical industries for more than 20 years. Our team's deep expertise, international network and proven strategic approach can help you successfully navigate the pathways to global market access.

Events & Webinars

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23 March

Asia Pacific Device Summit

The Nixon Library Yorba Linda, California
30 November
11 January

BIO Partnering at JPM

Virtual. 11-15 January 2021.

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Biomedical Industry Updates

Biomedical news, views, insights and case studies from across the globe.

Pile of Documents

DOC’s will need to be submitted for new Class I IVD ARTG registrations

Similarly, to TGA’s recent notification on 1 October 2020, the TGA has issued a notice of upcoming changes for Class IVD registrations via an email...
shutterstock_412781575

Formulated ingredients and premixes: Keeping the IP of a PI

Formulated ingredients or premixes are commonly used in many medicinal products – such as inks, coatings and colourants, fragrances and flavours, dosage form bases, and...
Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes,...

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